Valve positioning device

ABSTRACT

Medical devices for positioning a valve in a subject&#39;s body, such as a prosthetic heart valve in a subject&#39;s heart, are disclosed. The prosthetic heart valve may include a valve assembly, a frame, and a control arm. The prosthetic heart valve may include a commissural post or multiple commissural posts. The prosthetic heart valve may include a positional marker on a control arm. The prosthetic heart valve may include multiple positional markers on one or more control arms. The positional markers can be shapes, characters, or other symbols. The positional markers may themselves be asymmetric. The positional markers may be placed in an asymmetric location on a control arm. The control arm may be asymmetrically shaped.

BACKGROUND

In many medical procedures, a device is inserted temporarily orpermanently into a patient. One example includes prosthetic heartvalves. Heart valves have been developed that can be inserted via aminimally invasive procedure. Often procedures are performed via acatheter-based delivery system, with the heart valve collapsed on thecatheter inserted into the patient, and the heart valve is then expandedwhen correctly positioned in the patient. The heart valve must beproperly positioned before final deployment in the patient.

Existing catheter-based methods prevent certain visualization techniquesfrom being used. Correct positioning of a heart valve prosthesisrelative to a native heart valve can be achieved by using radiographicimages, including fluoroscopy in some cases. Certain radiographic imagesare two dimensional and do not indicate depth. More importantly, certainradiographic images do not provide an easily identifiable device todistinguish whether the heart valve prosthesis is correctly positionedand do not provide a device to distinguish how the device is orientedwithout further investigation. Incorrect positioning of a heart valveprosthesis can lead to patient complications. Physicians interpret theradiographic image and adjust the position of the prosthetic heart valveas needed. Physicians thus need a device that can help in quickly andaccurately positioning the heart valve prosthesis relative to the nativeheart valve and directly illustrate how the heart valve prosthesis iscurrently oriented.

BRIEF SUMMARY

In accordance with some embodiments, a prosthetic heart valve isdisclosed. This heart valve prosthesis includes a valve assembly, aframe, and a control arm. The frame may include commissural posts. Thecontrol arm, also known as an engagement arm, may include a positionalmarker. The positional marker is positioned on a control arm of theprosthetic heart valve. The prosthetic heart valve may have one, two, ormore control arms. The positional marker can be a symbol, shape,character, letter, or any other indicator. The positional marker may bemade of a material with a different radiopacity than other portions ofthe prosthetic heart valve. The prosthetic heart valve may include apositional marker on one control arm, a positional marker on two controlarms, or a positional marker on more than two control arms. Theprosthetic heart valve may include multiple positional markers on one,two, or more control arms.

The positional marker may be asymmetric. The positional marker may bepositioned closer to a first commissural post than a second commissuralpost. The control arm may also be asymmetric separate from or inconjunction with an asymmetric positional marker. The positional markermay provide a means to orient the prosthetic heart valve with a nativeheart valve. The positional marker may provide a means to orient theprosthetic heart valve with a native heart valve in conjunction withother elements of the heart valve.

In some embodiments a prosthetic heart valve comprises a biologicalvalve assembly, a frame coupled to the biological valve assembly, theframe comprising a first commissural post, a second commissural post,and a control arm attached to the first commissural post and the secondcommissural post.

In some embodiments the control arm forms a shape between thecommissural posts. In some embodiments the control arm further comprisesa positional marker.

In some embodiments the control arm forms a symmetric shape between thefirst commissural post and the second commissural post. In someembodiments the positional marker is positioned on the control armcloser to one commissural post than another commissural post.

In some embodiments the positional marker comprises a bend in thecontrol arm.

In some embodiments the positional marker comprises multiple bends inthe control arm.

In some embodiments the positional marker comprises a geometric shape.

In some embodiments the positional marker comprises a character.

In some embodiments the positional marker comprises an asymmetriccharacter.

In some embodiments the positional marker comprises an asymmetric shape.

In some embodiments the frame comprises a first material with a firstradiopacity, and wherein the positional marker comprises a secondmaterial with a second radiopacity.

In some embodiments the commissural posts comprise a first material witha first radiopacity, and wherein the positional marker comprises asecond material with a second radiopacity.

In some embodiments the prosthetic heart valve comprises the positionalmarker welded to the control arm.

In some embodiments the shape of the control arm between the commissuralposts is asymmetric.

In some embodiments the assembly further comprises a second control arm,and wherein the shape of each control arm is asymmetric.

In some embodiments the shape of each control arm differs from all othercontrol arms.

Some embodiments provide a method of implanting a prosthetic heartvalve, the method comprising placing a prosthetic heart valve at leastpartially in a heart of a subject. In some embodiments the prostheticheart valve comprises a valve assembly, a frame, and two or morecommissural posts coupled to the frame, the posts being arrangedcircumferentially around a central longitudinal axis of the valveassembly, and the frame is configured to assume a collapsed state and anexpanded state, and a control arm attached to two different commissuralposts, and the control arm having a positional marker.

In some embodiments placing the prosthetic heart valve in a heart of asubject comprises placing the prosthetic heart valve in a vicinity of anative heart valve having native commissures, while the commissuralposts are in the collapsed state. In some embodiments the methodcomprises generating a fluoroscopic image of the native commissures andthe prosthetic heart valve. In some embodiments the method comprisesdetermining whether one post of the prosthetic heart valve is alignedwith one native commissure and determining the position of thepositional marker relative to the native heart valve. In someembodiments the method comprises rotating the prosthetic heart valve tocorrect a rotational alignment of the prosthetic heart valve with thenative commissure.

In some embodiments the posts are in the expanded state after theprosthetic heart valve is rotated.

In some embodiments the prosthetic heart valve comprises multiplecontrol arms, and wherein each control arm includes a positional marker.

In some embodiments the method further comprises that verifying theprosthetic heart valve is rotationally aligned after rotating the valveassembly.

In some embodiments prosthetic heart valve comprises a valve assembly, aframe coupled to the valve assembly, the frame comprises a firstcommissural post, a second commissural post, a control arm attached totwo commissural posts. In some embodiments the control arm forms asymmetric arc between the commissural posts. In some embodiments thecontrol arm comprises a positional indicator.

In some embodiments the positional indicator comprises a radiographicmarker.

In some embodiments the positional indicator is asymmetric.

The embodiments and related concepts will be more fully understood fromthe following detailed description of the embodiments thereof.

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1-5 illustrate a prosthetic heart valve including a positionalmarker in accordance with some embodiments;

FIG. 6 illustrates a prosthetic heart valve being positioned relative toa native heart valve in accordance with some embodiments;

FIGS. 7a, 7b , and 8-10 illustrate a prosthetic heart valve including apositional marker in accordance with some embodiments;

FIG. 11 illustrates a subject's heart in accordance with someembodiments; and

FIGS. 12 and 13 illustrate a prosthetic heart valve being positionedrelative to a native heart valve in accordance with some embodiments.

DETAILED DESCRIPTION OF EMBODIMENTS

While the disclosure refers to illustrative embodiments for particularembodiments, it should be understood that the disclosure is not limitedthereto. Modifications can be made to the embodiments described hereinwithout departing from the spirit and scope of the present disclosure.Those skilled in the art with access to this disclosure will recognizeadditional modifications, embodiments, and embodiments within the scopeof this disclosure and additional fields, in which the disclosedexamples could be applied. Therefore, the following detailed descriptionis not meant to be limiting. Further, it is understood that theapparatus and methods described below can be implemented in manydifferent embodiments of hardware. Any actual hardware described is notmeant to be limiting. The operation and behavior of the apparatus andmethods presented are described with the understanding thatmodifications and variations of the embodiments are possible.

References to “one embodiment,” “an embodiment,” “some embodiments,” “incertain embodiments,” etc., indicate that the embodiment described mayinclude a particular feature, structure, or characteristic, but everyembodiment may not necessarily include the particular feature,structure, or characteristic. Moreover, such phrases are not necessarilyreferring to the same embodiment. Further, when a particular feature,structure, or characteristic is described in connection with anembodiment, it is submitted that it is within the knowledge of oneskilled in the art to affect such feature, structure, or characteristicin connection with other embodiments whether or not explicitlydescribed.

Reference is now made to FIG. 1 that includes a schematic illustrationof a prosthetic heart valve 100. In some embodiments, the prostheticheart valve 100 may include a valve assembly 110 and a frame 120. Insome embodiments the frame 120 may comprise commissural posts 122. Insome embodiments there may be one, two, three, or more commissural posts122 comprising the frame 120 of the prosthetic heart valve 100. In someembodiments the frame 120 has multiple sections and those sections arearranged in a cylindrical shape. This cylindrical shape may be expandedor compressed in certain areas as necessary or desired for valvepositioning or implantation.

The valve assembly 110 may comprise any biocompatible material. Thevalve assembly 110 may comprise any biological material. For examplevalve assembly 110 may comprise bovine, porcine, or equine tissue, suchas valve tissue or pericardium. The valve assembly 110 may comprise anynatural tissue. Valve assembly 110 may comprise multiple piecesstitched, joined, attached or otherwise coupled to each other.

In some embodiments the frame 120 has multiple sections and thosesections are arranged along a longitudinal axis. The frame 120 may becomprised of any suitable material, for example nitinol or stainlesssteel.

In addition to having commissural posts 122, the prosthetic heart valve100 may also include a control arm 130. In some embodiments, theprosthetic heart valve 100 may include one, two, three, or more controlarms 130. Control arms 130 can extend from one commissural post 122 toanother in various shapes including an arc, a line, or various othershapes. The shapes of the control arms 130 can also vary so that eachprosthetic heart valve 100 having two or more control arms 130 mayinclude control arms 130 of different shapes. The control arms 130 maybe comprised of any suitable material, for example nitinol or stainlesssteel.

FIG. 1 illustrates one potential embodiment of a heart valve 100. FIG. 1shows a prosthetic heart valve 100 comprising a valve assembly 110 andframe 120. In accordance with some embodiments, the frame 120 mayinclude three commissural posts 122. In some embodiments the prostheticheart valve 100 may include three control arms 130. In some embodimentsone of the control arms 130 may include a positional marker 132. In someembodiments the positional marker 132 may comprise a bend in the controlarm 130. In some embodiments the positional marker 132 may comprisemultiple bends in the control arm 130. In some embodiments the controlarm 130 comprises an arc shape that extends between the commissuralposts 122 of the prosthetic heart valve 100.

In some embodiments the positional marker 132 can be positioned atvarious locations along the control arm 130. In some embodiments thepositional marker 132 can be positioned symmetrically at the lowestpoint of the arc formed by control arm 130. In some embodiments thepositional marker 132 can be positioned asymmetrically about the controlarm 130. For example, positional marker 132 can be positioned above thelowest point of the arc formed by control arm 130.

In addition, positional marker 132 may comprise a material with adifferent radiopacity than other portions of the prosthetic heart valve100. In some embodiments, the positional marker 132 may have differentradiopacity from the control arm 130. In some embodiments, thepositional marker 132 may have different radiopacity from the frame 120.In some embodiments, the positional marker 132 may have differentradiopacity from the commissural posts 122. In some embodiments, thepositional marker 132 may have different radiopacity from all otherportions of the prosthetic heart valve 100.

FIG. 2 illustrates a prosthetic heart valve 100 including a valveassembly 110, frame 120, and commissural posts 122. FIG. 2 illustratesan embodiment with three commissural posts 122 and three control arms130. FIG. 2 illustrates an embodiment where a control arm 130 includes apositional marker 132 identified by a geometric shape. The shape mayinclude a square, circle, oval, triangle, rectangle, or any othergeometric shape. In addition, FIG. 2 illustrates that the positionalmarker 132 is offset and asymmetrically positioned on the control arm130. In FIG. 2 positional marker 132 is positioned off to the left sideof the control arm 130 and is closer to one commissural post 122 thananother commissural post 122. This provides an asymmetric shape of thecontrol arm 130. In some embodiments the control arm 130 comprises awire. In some embodiments the positional marker 132 comprises a bend inthe wire of the control arm 130. In some embodiments the positionalmarker 132 comprises multiple bends in the wire of the control arm 130.

As shown, positional marker 132 is centered about the wire of controlarm 130. However, positional marker 132 can be positioned interior to orexterior from the arc formed by control arm 130. In some embodiments,the positional marker 132 may comprise a bend in control arm 130.

In some embodiments, the positional marker 132 may comprise multiplebends in control arm 130. In some embodiments, bends may be toward theframe 120. In some embodiments, bends may be away from the frame 120. Insome embodiments the positional marker 132 may be positioned on the sideof control arm 130 closer to the frame 120. In some embodiments thepositional marker 132 may be positioned on the side of control arm 130away from the frame 120. In some embodiments the positioning of thepositional marker 132 relative to the control arm 130 may provide addedbenefits. For example, when the positional marker 132 is positioned onthe side of the control arm 130 toward the frame, the positional marker132 may provide additional pressure on the native leaflets of the nativeheart valve 210 proximate the control arms 130. In addition, when thepositional marker 132 is positioned on the side of the control arm 130away the frame, the positional marker 132 may provide additionalpressure on other portions of the native heart valve 210 proximate thecontrol arms 130.

In some embodiments, the geometric shape can be rotated in any desirableconfiguration that may help to identify the configuration of theprosthetic heart valve 100. In addition to geometric shapes, othershapes as would be understood or contemplated by one of ordinary skillin the art could be used. In some embodiments, symbols, logos, initialsor other identifying characteristics could be used.

FIG. 3 illustrates a prosthetic heart valve 100 that includes a valveassembly 110, a frame 120, and control arms 130. In some embodiments,the frame 120, as shown in FIG. 3, may include multiple commissuralposts 122. FIG. 3 illustrates an embodiment where the positional marker132 comprises an asymmetric shape. In some embodiments this asymmetricshape may include an asymmetric character. In some embodiments thisasymmetric shape may include an asymmetric letter.

In some embodiments this asymmetric shape may be positioned at multiplepoints on the control arm 130. In some embodiments the asymmetric shapeof the positional marker 132 may be positioned closer to one commissuralpost 122 than another commissural post 122. This provides two levels ofidentification to examine whether the prosthetic heart valve 100 ispositioned appropriately. By having the positional marker 132 comprisean asymmetric shape and having the positional marker 132 alsoasymmetrically positioned on the control arm 130 there are two checks todetermine which way the heart valves is oriented.

In some embodiments the asymmetric shape can be positioned to reflect aneasily identifiable orientation to aid in identifying the position ofthe prosthetic heart valve 100. The asymmetric shape can be positionedin any orientation. For example, in some embodiments the asymmetricshape of positional marker 132 may comprise a character. In someembodiments, the asymmetric shape of positional marker 132 may comprisea letter of an alphabet. In some embodiments, as shown in FIG. 3 theasymmetric shape of the positional marker 132 may comprise the letter“E.” For example, the “E” as positioned on the control arm 130 may facesuch that the three extending portions of the capital “E” extend towardthe center line of the prosthetic heart valve 100 as illustrated in FIG.3. In some embodiments the three extending portions of the capital “E”may extend away from the center of the prosthetic heart valve 100 oroutward.

In some embodiments when the positional marker 132 is used at certainpositions of the control arm 130 the asymmetric shape can be positionedsuch that the three extending portions will extend upward toward valveassembly 110. In other embodiments the three extending prongs of the “E”or asymmetric shape which may comprise positional marker 132 may extendtoward the bottom of the frame 120, away from valve assembly 110.

FIG. 4 illustrates a prosthetic heart valve 100 which may comprise avalve assembly 110, frame 120, and control arms 130. In addition theframe 120 may comprise commissural posts 122. FIG. 4 illustrates anembodiment where multiple positional markers 132 are used on a controlarm 130. This embodiment illustrates using similar positional markers132 both positioned on one portion of the control arm 130.

In some embodiments multiple positional markers 132 can be positionedcloser to one commissural post 122 and farther away from anothercommissural post 122. In some embodiments using multiple positionalmarkers 132 may provide an easier identifiable position of prostheticheart valve 100 when a person examines the configuration of theprosthetic heart valve 100.

In some embodiments two different positional markers 132 could be usedon the same control arm 130. In some embodiments a shape could be usedand a different symbol could be used in conjunction with the shape. Forexample in some embodiments a triangle could be used as well as acharacter could be used on the same control arm 130.

In some embodiments the positional markers 132 can both be positioned toindicate, direct, or point in the same direction as shown in FIG. 4. InFIG. 4 the two positional markers 132 are embodied by triangles. In someembodiments the multiple positional markers 132 can indicate onedirection or another. As shown in FIG. 4, the positional markers pointaway from the center of the prosthetic heart valve 100 in atwo-dimensional image. In some embodiments the positional markers 132can point away from the center. In some embodiments the positionalmarkers 132 can point towards the center. In some embodiments thepositional markers 132 can point upward. In some embodiments thepositional markers 132 can point downward. In some embodiments thepositional markers 132 can point in any direction.

FIG. 5 illustrates a prosthetic heart valve 100 comprising a valveassembly 110, frame 120, and control arms 130. The frame 120 may includecommissural posts 122. In some embodiments, as shown in FIG. 5, thepositional marker may comprise a directional marker, such as an arrow.This arrow illustrates an asymmetric shape which can point, direct,indicate, or illustrate a certain direction of the valve when the valveis oriented in an appropriate matter. For example, if the valve ispositioned such that the control arm 130 is proximate the viewer when animage is taken the arrow can point right, as illustrated in FIG. 5.Conversely, if the control arm 130 was positioned at the back of theimage, or distal the viewer, the arrow would point or indicate left.

In some embodiments the positional markers 132 can be a separate elementfrom control arms 130 where the positional markers 132 are appropriatelyattached to control arms 130. In some embodiments positional markers 132can be coupled to a control arm 130. In some embodiments positionalmarkers 132 may be welded to control arms 130. In some embodimentspositional markers 132 may be molded or otherwise connected to a controlarm 130. One of ordinary skill in the art will understand themultiplicity of ways positional markers 132 could be attached to controlarms 130 if they were created as separate parts.

In addition, a control arm 130 and a positional marker 132 can be anintegral part.

Positional markers 132 can be made of any suitable material that can beintroduced into a subject. This would include, but is not limited to,metals, plastics, polymers, a biocompatible material, and any othersuitable material known to a person of ordinary skill in the art.

FIG. 6 illustrates another embodiment. In some embodiments theprosthetic heart valve 100 is at least partially placed in the subject'sheart 200. The prosthetic heart valve 100 may comprise two commissuralposts 122, a valve assembly 110, a frame 120, a control arm 130, and apositional marker 132. In some embodiments there may be three or morecommissural posts 122. In some embodiments commissural posts 122 can bearranged around a central longitudinal axis of the prosthetic heartvalve 100. In some embodiments the prosthetic heart valve 100 and itsassociated parts, including valve assembly 110, frame 120, commissuralposts 122, control arm 130, and positional marker 132, are configured toassume a collapsed state. In some embodiments the prosthetic heart valve100 is configured to assume an expanded state.

In some embodiments the prosthetic heart valve 100 includes threecontrol arms 130. In some embodiments each control arm 130 is attachedto two different commissural posts 122. Where prosthetic heart valve 100includes multiple commissural posts 122 and multiple control arms 130,the prosthetic heart valve 100 may include one or more positionalmarkers 132 on one control arm 130. In some embodiments two control arms130 of prosthetic heart valve 100 may each include a positional marker132. In some embodiments every control arm 130 may include a positionalmarker 132. In some embodiments each control arm 130 may include one ormore positional markers 132.

In some embodiments the prosthetic heart valve 100 is placed in thesubject's heart 200. In some embodiments placing the prosthetic heartvalve 100 in the subject's heart 200 includes placing the valve in avicinity of a native heart valve 210. In some embodiments the nativeheart valve 210 may include native commissures 212. In some embodimentspositioning the prosthetic heart valve 100 relative to the native heartvalves 210 is performed by aligning commissural posts 122 with nativecommissures 212. In some embodiments the prosthetic heart valve 100 isconfigured to collapse to a collapsed state. In some embodiments theprosthetic heart valve 100 is configured to expand to an expanded state.

In some embodiments the prosthetic heart valve 100 is positioned in thesubject's heart 200 via a blood vessel. In some embodiments after theprosthetic heart valve 100 is positioned in the subject's heart 200, aradiographic or fluoroscopic image may be generated. In some embodimentsthe radiographic or fluoroscopic image may depict at least a portion ofprosthetic heart valve 100 and at least a portion of the native heartvalve 210. In some embodiments prosthetic heart valve 100 may bepositioned relative to a portion of the native heart valve 210 based onthe image. In some embodiments prosthetic heart valve 100 may be rotatedrelative to a portion of the native heart valve 210 based on the image.

In some embodiments prosthetic heart valve 100 may be aligned relativeto a portion of the native heart valve 210 based on the image. In someembodiments the prosthetic heart valve 100 may be expanded to anexpanded state or a partially expanded state while it is positioned,rotated, or aligned with a portion of native heart valve 210. In someembodiments the prosthetic heart valve 100 may be expanded to anexpanded state after it is positioned, rotated, or aligned with aportion of native heart valve 210.

In some embodiments the configuration of the prosthetic heart valve 100relative to the native heart valve 210 can be performed by examining theposition of the control arms 130. In some embodiments the configurationof the prosthetic heart valve 100 relative to the native heart valve 210can be performed by examining the position of the positional marker 132.In some embodiments, the positional marker 132 is asymmetrically placedon one control arm 130.

Prosthetic heart valve 100 may include a valve portion 110, frame 120,and two commissural posts 122, as shown in FIGS. 7a and 7b . In someembodiments the control arm 130 may be asymmetric. In some embodimentsthe control arm 130 may have straight bends making it asymmetric. Insome embodiments the control arm 130 may have curved bends, asillustrated in FIGS. 7a and 7b . In some embodiments, the control arm130 may have a straight and a curved bend or multiple straight andmultiple curved bends. In some embodiments the asymmetric control arm130 can be configured in such a way that one examining the configurationof prosthetic heart valve 100 will be able to quickly and easilydetermine how prosthetic heart valve 100 is oriented.

In some embodiments prosthetic heart valve 100 may include a valveportion 110, a frame 120, two commissural posts 122, and two or morecontrol arms 130. In some embodiments each control arm 130 may include adifferent positional marker 132. In some embodiments the control arm 130may serve as the positional marker 132.

In some embodiments each control arm 130 may be configured differently.In some embodiments each control arm 130 may be shaped differently suchthat one examining the orientation of prosthetic heart valve 100 candetermine which control arm 130 is positioned relative to the personexamining the prosthetic heart valve 100, the subject's heart 200, thenative heart valve 210, and/or the native commissures 212.

In some embodiments, as illustrated in FIG. 8, the control arms 130 mayinclude different positional markers 132 to readily identify eachcontrol arm 130 from another control arm 130. In some embodiments thecontrol arms 130 may include multiple bends as shown in FIG. 8. In someembodiments the control arms 130 may include multiple straight portions.In some embodiments multiple types or forms of positional markers 132can be used.

In some embodiments, as shown in FIG. 9, this bend or positional marker132A may be toward the frame 120 in the z-direction. In someembodiments, this bend or positional marker 132B may be away from theframe 120 in the z-direction.

In some embodiments a different positional marker 132 can be used oneach control arm. For example in a prosthetic heart valve 100 comprisingthree control arms 130, each control arm 130 may have a different typeof positional marker 132. A first control arm 130 can have a bends toserve as positional marker 132. A second control arm can have acharacter to serve as positional marker 132. A third control arm 130 mayinclude a geometric shape to serve as positional marker 132.

In some embodiments similar types of positional markers 132 may be usedon multiple control arms 130 or different embodiments of the positionalmarker 132 may be used. For example on a prosthetic heart valve 100including three control arms 130, one control arm 130 may have a “C” toserve as a positional marker, one control arm 130 may have a “D” toserve as a positional marker, and one control arm 130 may have a “E” toserve as a positional marker.

In some embodiments that include multiple control arms 130, each controlarm 130 make may include a differently shaped positional marker 132. Insome embodiments with three control arms 130 one control arm 130 mayinclude a positional marker 132 shaped like a rectangle, one control arm130 could include a positional marker 132 shaped like a triangle, andone control arm 130 could include a positional marker 132 shaped like anoval.

FIG. 10 illustrates a subject's heart 200, which contains four nativeheart valves. Native heart valves include an aortic native heart valve210, mitral valve 220, tricuspid valve 230, and pulmonary valve 240. Insome embodiments the prosthetic heart valve 100 may be positioned withina subject's heart 200. The prosthetic heart valve 100 may be positionedproximate any native heart valve, including the aortic valve, mitralvalve, tricuspid valve, or pulmonary valve. In addition any discussionof a prosthetic heart valve 100 being positioned proximate one type ofnative valve, such as an aortic native heart valve 210 should beunderstood as contemplating the same or a similar prosthetic heart valve100 being implanted in any other type of heart valve, such as a mitralvalve 220, tricuspid valve 230, or pulmonary valve 240.

FIG. 11 illustrates a prosthetic heart valve 100 in situ aftercompletion of the implantation procedure, in accordance with someembodiments of the present invention. In this embodiment, commissuralposts 122 are positioned above respective native commissures 212,without impacting the native commissures 212 (i.e., touching or pushingthe commissures). In other words, there may be space between each ofcommissural posts 122 and its respective native commissure 212.

Control arms 130 (also sometimes described as engagement arms) having apositional marker 132 are positioned within native sinuses 214, suchthat the ends of the control arms 130 touch the floors of the nativesinuses 214. The positional marker 132 shown in this figure is onlyexemplary, and any other positional marker may be used. In thisembodiment, the number of control arms 130 is typically equal to thenumber of native sinuses 214 of the native valve, and the control arms130 are radially separated by approximately equal angles. Thethree-dimensional shape of control arms 130 causes the ends of thecontrol arms 130 to find the lowest point of reach within the floors ofthe native sinuses 214, thereby enabling self-alignment of prostheticheart valve 100 proximate the native heart valve 210 and nativecommissures 212.

As illustrated by FIG. 11, the prosthetic heart valve 100 withcorresponding control arm 130 and positional marker 132 may beconfigured to be positioned proximate an aortic native heart valve 210.As one of skill in the art would appreciate a prosthetic heart valve 100configured to be positioned proximate an aortic native heart valve 210may have similar characteristics to a prosthetic heart valve 100configured to be positioned in a pulmonary valve 240. Some similarcharacteristics may include orientation or structure of the prostheticheart valve 100, upstream and downstream orientation of the prostheticheart valve 100, and others.

In typical human subjects, the native heart valve 210 has three nativecommissures 212, which define respective commissural high points, andthree respective sinus low points. Prosthetic heart valve 100 isconfigured to match these high and low points. Such matching enablesaxial anchoring, without forced bending, crimping, or folding over ofthe leaflets, and without impinging on the commissures. In this way,prosthetic heart valve 100 embraces the leaflets, rather than squeezingthem.

For some applications, control arms 130 are generally aligned with thenative leaflets, thereby avoiding local deformation, and distributingforce over a larger contiguous area of the leaflet surface.

In some embodiments the prosthetic heart valve 100 is configured to bepositioned proximate a native mitral valve 220, as illustrated in FIG.12. In some embodiments the prosthetic heart valve 100 that includescontrol arm 130 and positional marker 132 is similar to the prostheticheart valve 100 discussed above, to be positioned proximate aorticnative heart valve 210. In some embodiments the prosthetic heart valve100 may include a valve assembly 110 which is oriented opposite thatused in procedures involving an aortic native heart valve 210. As FIG.12 illustrates, the upstream side of prosthetic heart valve 100 may bethe end of the frame configured to expand to a larger cross-sectionalarea. The downstream side of prosthetic heart valve 100 may be the endof the frame configured to expand to a smaller cross-sectional area.

FIG. 13 illustrates a prosthetic heart valve positioned proximate themitral valve 220. In this orientation the prosthetic heart valve 100 andassociated control arms 130 with positional marker 132 may hold withoutsqueezing leaflets of mitral valve 220. In some embodiments the upstreamsection of prosthetic heart valve 100 is released from the deliverydevice and is expanded to press against the interior wall of nativemitral valve 220. In other embodiments the upstream section isconfigured to prevent the prosthetic heart valve 100 from migrating.

As illustrated by FIG. 13, the prosthetic heart valve 100 withcorresponding control arm 130 and positional marker 132 may beconfigured to be positioned proximate a mitral valve 220. As one ofskill in the art would appreciate a prosthetic heart valve 100configured to be positioned proximate a mitral valve 220 may havesimilar characteristics to a prosthetic heart valve 100 configured to bepositioned in a tricuspid valve 230. Some similar characteristics mayinclude orientation or structure of the prosthetic heart valve 100,upstream and downstream orientation of the prosthetic heart valve 100,and others.

The foregoing description has been presented for purposes ofillustration and description. It is not intended to be exhaustive or tolimit the precise embodiments disclosed. Other modifications andvariations may be possible in light of the above teachings. Theembodiments and examples were chosen and described in order to bestexplain the principles of the embodiments and their practicalapplication, and to thereby enable others skilled in the art to bestutilize the various embodiments with modifications as are suited to theparticular use contemplated. By applying knowledge within the skill ofthe art, others can readily modify and/or adapt for various applicationssuch specific embodiments, without undue experimentation, withoutdeparting from the general concept. Therefore, such adaptations andmodifications are intended to be within the meaning and range ofequivalents of the disclosed embodiments, based on the teaching andguidance presented herein.

1-20. (canceled)
 21. A prosthetic heart valve comprising: a valveassembly; an expandable frame coupled to the valve assembly, theexpandable frame configured to expand within a native valve annulus, theexpandable frame including at least two commissural posts, eachcommissural post being arranged around a central longitudinal axis ofthe prosthetic heart valve and being configured to align with a nativecommissure of a native heart valve; and at least two control armsdisposed circumferentially about the expandable frame when theexpandable frame is in an expanded configuration, wherein each controlarm forms an arc between a pair of commissural posts with a first endattached to one commissural post of the pair of commissural posts and asecond end attached to the other commissural post of the pair ofcommissural posts, wherein at least one of the at least two control armsis an asymmetric control arm that includes a positional marker betweenthe first and second ends thereof, the positional marker positioned onthe asymmetric control arm closer to one commissural post of the pair ofcommissural posts than to the other commissural post of the pair ofcommissural posts such that the asymmetric control arm has an asymmetricshape between the first and second ends thereof, the asymmetric shape ofthe asymmetric control arm being asymmetric relative to the centrallongitudinal axis of the prosthetic heart valve, and wherein theasymmetric shape of the asymmetric control arm differs from a shape ofall other control arms of the at least two control arms of theprosthetic heart valve.
 22. The prosthetic heart valve of claim 21,wherein the positional marker is a geometric shape.
 23. The prostheticheart valve of claim 22, wherein the geometric shape is asymmetric. 24.The prosthetic heart valve of claim 21, wherein the positional marker isa letter.
 25. The prosthetic heart valve of claim 21, wherein thepositional marker is at least one bend formed on the asymmetric controlarm.
 26. The prosthetic heart valve of claim 28, wherein the positionalmarker is multiple bends formed on the asymmetric control arm.
 27. Theprosthetic heart valve of claim 21, wherein the positional marker iswelded to the asymmetric control arm.
 28. The prosthetic heart valve ofclaim 21, wherein the expandable frame comprises a first material with afirst radiopacity, and wherein the positional marker comprises a secondmaterial with a second radiopacity.
 29. The prosthetic heart valve ofclaim 21, wherein the at least two commissural posts comprise a firstmaterial with a first radiopacity, and wherein the positional markercomprises a second material with a second radiopacity.
 30. Theprosthetic heart valve of claim 21, wherein the at least two commissuralposts include a first commissural post and a second commissural post,the at least two control arms include a first control arm and a secondcontrol arm, the first control arm forms the arc between the firstcommissural post and the second commissural post, and the second controlarm forms the arc between second commissural post and the firstcommissural post.
 31. The prosthetic heart valve of claim 21, whereinthe at least two commissural posts include a first commissural post, asecond commissural post, and a third commissural post, and wherein theat least two control arms include a first control arm, a second controlarm, and a third control arm, and wherein the first control arm formsthe arc between the first commissural post and the second commissuralpost, and wherein the second control arm forms the arc between secondcommissural post and the third commissural post, and wherein the thirdcontrol arm forms the arc between the third commissural post and thefirst commissural post.
 32. A prosthetic heart valve comprising: a valveassembly; and an expandable frame coupled to the valve assembly, theexpandable frame configured to expand within a native valve annulus, theexpandable frame including exactly two commissural posts including afirst commissural post and a second commissural post, wherein eachcommissural post is arranged around a central longitudinal axis of theprosthetic heart valve and is configured to align with a nativecommissure of a native heart valve; and exactly two control armsdisposed circumferentially about the expandable frame when theexpandable frame is in an expanded configuration, the exactly twocontrol arms including a first control arm and a second control arm,wherein each control arm forms an arc between the first and secondcommissural posts with a first end attached to one of the twocommissural posts and a second end attached to the other of the twocommissural posts, and wherein the first control arm includes apositional marker between the first and second ends thereof, thepositional marker positioned on the first control arm closer to thefirst commissural post than to the second commissural post such that thefirst control arm has an asymmetric shape between the first and secondends thereof, the asymmetric shape of the first control arm between thesecond and first commissural posts being asymmetric relative to thecentral longitudinal axis of the prosthetic heart valve, and wherein theasymmetric shape of the first control arm differs from a shape of thesecond control arm.
 33. The prosthetic heart valve of claim 32, whereinthe positional marker is a geometric shape, a letter, or an arrow. 34.The prosthetic heart valve of claim 32, wherein the first and secondcommissural posts comprise a first material with a first radiopacity,and wherein the positional marker comprises a second material with asecond radiopacity.
 35. The prosthetic heart valve of claim 32, whereinthe positional marker is a bend formed on the first control arm.
 36. Theprosthetic heart valve of claim 32, wherein the positional marker ismultiple bends formed on the first control arm.
 37. A prosthetic heartvalve comprising: a valve assembly; and an expandable frame coupled tothe valve assembly, the expandable frame configured to expand within anative valve annulus; a positional marker; and at least one asymmetriccontrol arm disposed circumferentially about the expandable frame whenthe expandable frame is in an expanded configuration with a first endand a second end being attached to the expandable frame atcircumferentially spaced apart locations, wherein the at least oneasymmetric control arm forms an arc between the first and second endsthereof, wherein the positional marker is attached to the asymmetriccontrol arm between the first and second ends thereof, the positionalmarker being positioned on the asymmetric control arm closer to thefirst end than to the second end such that the asymmetric control armhas an asymmetric shape between the first and second ends thereof, theasymmetric shape of the asymmetric control arm being asymmetric relativeto a central longitudinal axis of the prosthetic heart valve, andwherein the positional marker is a geometric shape, a letter, or anarrow.
 38. The prosthetic heart valve of claim 37, wherein thepositional marker is a geometric shape and the geometric shape isasymmetric.
 39. The prosthetic heart valve of claim 37, wherein thepositional marker is a letter and the letter is asymmetric.
 40. Theprosthetic heart valve of claim 37, wherein the positional marker is anarrow and the arrow is asymmetric.